External steerable fiber for use in endoluminal deployment of expandable devices

ABSTRACT

The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/658,597, entitled EXTERNAL STEERABLE FIBER FOR USE IN ENDOLUMINALDEPLOYMENT OF EXPANDABLE DEVICES, filed Oct. 23, 2012, now U.S. Pat. No.9,782,282 B2, issued on Oct. 10, 2017, which claims priority to U.S.Provisional Application Ser. No. 61/559,408, entitled EXTERNABLESTEERABLE FIBER FOR USE IN ENDOLUMINAL DEPLOYMENT OF EXPANDABLE DEVICES,filed Nov. 14, 2011, which is hereby incorporated by reference in itsentirety.

BACKGROUND Field

The present disclosure relates generally to endoluminal devices and,more specifically, to steering expandable endoluminal devices within thevasculature of a patient.

Discussion of the Related Art

Endoluminal therapies typically involve the insertion of a deliverycatheter to transport an implantable prosthetic device into thevasculature through a small, often percutaneous, access site in a remotevessel. Once access to the vasculature is achieved, the deliverycatheter is used to mediate endoluminal delivery and subsequentdeployment of the device via one of several techniques. In this fashion,the device can be remotely implanted to achieve a therapeutic outcome.In contrast to conventional surgical therapies, endoluminal treatmentsare distinguished by their “minimally invasive” nature.

Expandable endoluminal devices can be comprised of a graft or a stentcomponent with or without a graft covering over the stent interstices.They can be designed to expand when a restraint is removed or to beballoon-expanded from their delivery diameter, through a range ofintermediary diameters, up to a maximal, pre-determined functionaldiameter. The endoluminal delivery and deployment of expandableendoluminal devices pose several unique problems. For example, theendoluminal device itself must be constrained in a suitable introductorysize (or delivery diameter) to allow insertion into the vasculature andmounted onto a delivery device such as a catheter shaft. In suchconfigurations, the endoluminal devices can be difficult to navigatethrough vasculature that has significant bending or curvature.

Therefore, it is desirable to provide systems for endoluminal deliveryof expandable endoluminal devices to vascular treatment sites,particularly along tortuous vasculature, such as along the aortic arch.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the description serve to explain the principles of thedisclosure, wherein:

FIG. 1 illustrates a side view of a catheter assembly having anexpandable implant;

FIGS. 2A and 2B illustrate perspective views of catheter assemblieshaving expandable implants;

FIGS. 3A-3B and 3C-3D illustrate cross-sectional and perspective views,respectively, of catheter assemblies having expandable implants;

FIGS. 4A-4D illustrate various profile views of a distal end of anexpandable implant;

FIGS. 5A-5D illustrate perspective views of a catheter assembly havingan expandable implant;

FIG. 6 illustrates a perspective view of an expandable implant;

FIGS. 7A-7H illustrate cross-sectional views of an expandable implantand sleeve with steering fibers;

FIG. 8 illustrates a cross-sectional view of catheter assembly having anexpandable implant; and

FIG. 9 illustrates a side view of a catheter assembly having anexpandable implant.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatuses configured to perform the intended functions. Stateddifferently, other methods and apparatuses can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying drawing figures referred to herein are not all drawn toscale, but can be exaggerated to illustrate various aspects of thepresent disclosure, and in that regard, the drawing figures should notbe construed as limiting.

Throughout this specification and in the claims, the term “distal”refers to a location that is, or a portion of an endoluminal device(such as a stent-graft) that when implanted is, further downstream withrespect to blood flow than another portion of the device. Similarly, theterm “distally” refers to the direction of blood flow or furtherdownstream in the direction of blood flow.

The term “proximal” refers to a location that is, or a portion of anendoluminal device that when implanted is, further upstream with respectto blood flow than another portion of the device. Similarly, the term“proximally” refers to the direction opposite to the direction of bloodflow or upstream from the direction of blood flow.

With further regard to the terms proximal and distal, and because thepresent disclosure is not limited to peripheral and/or centralapproaches, this disclosure should not be narrowly construed withrespect to these terms. Rather, the devices and methods described hereincan be altered and/or adjusted relative to the anatomy of a patient.

Throughout this specification and in the claims, the term “leading”refers to a relative location on a device which is closer to the end ofthe device that is inserted into and progressed through the vasculatureof a patient. The term “trailing” refers to a relative location on adevice which is closer to the end of the device that is located outsideof the vasculature of a patient.

In various embodiments, a catheter assembly is disclosed which utilizesone or more flexible sleeves that (i) releasably constrain an expandableimplant, such as an expandable endoluminal stent graft, in a dimensionsuitable for endoluminal delivery of the implant to a treatment site,such as a vascular member in a patient's body; and (ii) furtherconstrain the implant to an outer peripheral dimension that is largerthan the dimension suitable for endoluminal delivery but smaller than anunconstrained or fully deployed outer peripheral dimension, therebyfacilitating selective axial and/or rotational positioning of theimplant at the treatment site prior to full deployment and expansion ofthe implant.

Various embodiments of the present disclosure comprise a catheterassembly configured to deliver an expandable implant to a treatment areaof the vasculature of a patient. In accordance with embodiments of thedisclosure, the catheter assembly includes at least one steering line.The steering line (or lines) allows for selective bending of theexpandable implant within the vasculature.

With initial reference to FIG. 1, a catheter assembly 100 in accordancewith the present disclosure comprises a catheter shaft 102, a main lumen103 and an expandable implant 106. Expandable implant 106 can compriseany endoluminal device suitable for delivery to the treatment area of avasculature. Such devices can include, for example, stents, grafts, andstent grafts.

In various embodiments, expandable implant 106 comprises a stent graft.Conventional stent grafts are designed to dilate from their deliverydiameter, through a range of intermediary diameters, up to a maximal,pre-determined functional diameter, and generally comprise one or morestent components with one or more graft members displaced over and/orunder the stent.

In various embodiments, expandable implant 106 comprises one or morestent components made of nitinol and a graft member made of ePTFE.However, and as discussed below, any suitable combination of stentcomponent(s) and graft member(s) is within the scope of the presentdisclosure.

For example, stent components can have various configurations such as,for example, rings, cut tubes, wound wires (or ribbons) or flatpatterned sheets rolled into a tubular form. Stent components can beformed from metallic, polymeric or natural materials and can compriseconventional medical grade materials such as nylon, polyacrylamide,polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate,polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene,polyvinylchloride, polyurethane, elastomeric organosilicon polymers;metals such as stainless steels, cobalt-chromium alloys and nitinol andbiologically derived materials such as bovine arteries/veins,pericardium and collagen. Stent components can also comprisebioresorbable materials such as poly(amino acids), poly(anhydrides),poly(caprolactones), poly(lactic/glycolic acid) polymers,poly(hydroxybutyrates) and poly(orthoesters). Any expandable stentcomponent configuration which can be delivered by a catheter is inaccordance with the present disclosure.

Moreover, potential materials for graft members include, for example,expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane,fluoropolymers, such as perfluorelastomers and the like,polytetrafluoroethylene, silicones, urethanes, ultra high molecularweight polyethylene, aramid fibers, and combinations thereof. Otherembodiments for a graft member material can include high strengthpolymer fibers such as ultra high molecular weight polyethylene fibers(e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g.,Technora®, etc.). The graft member can include a bioactive agent. In oneembodiment, an ePTFE graft includes a carbon component along a bloodcontacting surface thereof. Any graft member which can be delivered by acatheter is in accordance with the present disclosure.

In various embodiments, a stent component and/or graft member cancomprise a therapeutic coating. In these embodiments, the interior orexterior of the stent component and/or graft member can be coated with,for example, a CD34 antigen. Additionally, any number of drugs ortherapeutic agents can be used to coat the graft member, including, forexample heparin, sirolimus, paclitaxel, everolimus, ABT-578,mycophenolic acid, tacrolimus, estradiol, oxygen free radical scavenger,biolimus A9, anti-CD34 antibodies, PDGF receptor blockers, MMP-1receptor blockers, VEGF, G-CSF, HMG-CoA reductase inhibitors,stimulators of iNOS and eNOS, ACE inhibitors, ARBs, doxycycline, andthalidomide, among others.

In various embodiments, expandable implant 106 can comprise a radiallycollapsed configuration suitable for delivery to the treatment area ofthe vasculature of a patient. Expandable implant 106 can be constrainedin a radially collapsed configuration and mounted onto a delivery devicesuch as catheter shaft 102. The diameter of the expandable implant 106in the collapsed configuration is small enough for the implant to bedelivered through the vasculature to the treatment area. In variousembodiments, the diameter of the collapsed configuration is small enoughto minimize the crossing profile of catheter assembly 100 and reduce orprevent tissue damage to the patient. In the collapsed configuration,the expandable implant 106 can be guided by catheter shaft 102 throughthe vasculature.

In various embodiments, expandable implant 106 can comprise a radiallyexpanded configuration suitable for implanting the device in thetreatment area of a patient's vasculature. In the expandedconfiguration, the diameter of expandable implant 106 can beapproximately the same as the vessel to be repaired. In otherembodiments, the diameter of expandable implant 106 in the expandedconfiguration can be slightly larger than the vessel to be treated toprovide a traction fit within the vessel.

In various embodiments, expandable implant 106 can comprise aself-expandable device, such as a self-expandable stent graft. Suchdevices dilate from a radially collapsed configuration to a radiallyexpanded configuration when unrestrained. In other embodiments,expandable implant 106 can comprise a device that is expanded with theassistance of a secondary device such as, for example, a balloon. In yetother embodiments, catheter assembly 100 can comprise a plurality ofexpandable implants 106. The use of a catheter assembly with any numberof expandable implants is within the scope of the present disclosure.

Various medical devices in accordance with the disclosure comprise asleeve or multiple sleeves. The sleeve or sleeves can constrain anexpandable implant device in a collapsed configuration for endoluminaldelivery of the implant to a treatment portion of the vasculature of apatient. For the purposes of the disclosure, the term “constrain” canmean (i) to limit the expansion, either through self-expansion orassisted by a device, of the diameter of an expandable implant or (ii)to cover or surround but not otherwise restrain an expandable implant(e.g., for storage or biocompatibility reasons and/or to provideprotection to the expandable implant and/or the vasculature). Forexample, catheter assembly 100 comprises sleeve 104. Sleeve 104surrounds and constrains expandable implant 106 to a reduced diameter.

After delivery of the expandable implant to the treatment portion of thevasculature of the patient, the sleeve or sleeves can be unconstrainedin order to allow the expandable implant to expand to its functionaldiameter and achieve the desired therapeutic outcome. In variousembodiments, the sleeve or sleeves can remain implanted while notinterfering with the expandable implant. In other embodiments, thesleeve or sleeves can be removed from the body of the patient aftersuccessful deployment of the expandable implant.

In various embodiments, an expandable implant is constrained by a singlesleeve which circumferentially surrounds the expandable implant. Forexample, with reference to FIG. 2B, catheter assembly 200 comprises asleeve 204. In various embodiments, sleeve 204 circumferentiallysurrounds expandable implant 206 and constrains it in a collapsedconfiguration, in which the diameter is less than the diameter of theunconstrained implant. For example, sleeve 204 can constrain expandableimplant 206 in a collapsed configuration for delivery within thevasculature.

In other embodiments, an expandable implant is constrained by aplurality of sleeves which circumferentially surround the expandableimplant. The plurality of sleeves can comprise at least two sleeveswhich circumferentially surround each other.

In various embodiments, sleeves can be tubular and serve to constrain anexpandable implant. In such configurations, sleeves are formed from asheet of one or more materials wrapped or folded about the expandableimplant. While the illustrative embodiments herein are described ascomprising one or more tubular sleeves, sleeves of any non-tubular shapethat corresponds to an underlying expandable implant or that areotherwise appropriately shaped for a given application are also withinthe scope of the present disclosure.

In various embodiments, sleeves are formed by wrapping or folding thesheet of material(s) such that two parallel edges of the sheet aresubstantially aligned. Said alignment can or can not be parallel to orcoaxial with the catheter shaft of a catheter assembly. In variousembodiments, the edges of the sheet of material(s) do not contact eachother.

In various embodiments, the edges of the sheet of material(s) do contacteach other and are coupled with a coupling member (as described below)an adhesive, or the like. In various other embodiments, the edges of thesheet of material(s) are aligned so that the edges of the same side ofthe sheet or sheets (e.g., the front/first major surface or back/secondmajor surface of the sheet) are in contact with each other. In stillother embodiments, the edges of opposite sides of the sheet ofmaterial(s) are in contact with each other, such that the edges overlapeach other, such that a portion of one side of the sheet is in contactwith a portion of the other side. Said another way, the front of thesheet can overlap the rear of the sheet, or vice versa.

In various embodiments, sleeves comprise materials similar to those usedto form a graft member. For example, a precursor flexible sheet used tomake the sleeve can be formed from a flattened, thin wall ePTFE tube.The thin wall tube can incorporate “rip-stops” in the form oflongitudinal high strength fibers attached or embedded into the sheet ortube wall.

The sheet of material(s) used to form the sleeve(s) can comprise aseries of openings, such that the openings extend from one edge of thesheet to the other. In such configurations, a coupling member can bewoven or stitched through the series of openings in the sheet ofmaterial(s), securing each of the two edges together and forming a tube.For example, in FIG. 1, coupling member 124 secures the edges of sleeve104 such that sleeve 104 maintains expandable implant 106 in a reduceddiameter.

In various embodiments, the coupling member can comprise a woven fiber.In other embodiments, the coupling member can comprise a monofilamentfiber. Any type of string, cord, thread, fiber, or wire which is capableof maintaining a sleeve in a tubular shape is within the scope of thepresent disclosure.

In various embodiments, a single coupling member can be used toconstrain the diameter of one or more sleeves. In other embodiments,multiple coupling members can be used to constrain the diameter of oneor more sleeves.

In various embodiments, once a suitable expandable implant is in acollapsed configuration, the expandable implant can be deployed withinthe vasculature of a patient. An expandable implant in a collapsedconfiguration can be introduced to a vasculature and directed by acatheter assembly to a treatment area of the vasculature. Once inposition in the treatment area of the vasculature, the expandableimplant can be expanded to an expanded configuration.

In various embodiments, when the expandable implant is in positionwithin the vasculature, the coupling member or members can be disengagedfrom the sleeve or sleeves from outside of the body of the patient,which allows the sleeve(s) to open and the expandable implant to expand.As discussed above, the expandable implant can be self-expanding, or theimplant can be expanded by a device, such as a balloon.

The coupling member or members can be disengaged from the sleeve orsleeves by a mechanical mechanism operated from outside of the body ofthe patient. For example, the member or members can be disengaged byapplying sufficient tension to the member or members. In anotherexample, a dial or rotational element can be attached to the couplingmember or members outside of the body. Rotation of the dial orrotational element can provide sufficient tension to, displace anddisengage the coupling member or members.

In other configurations, coupling member or members can be disengaged bynon-mechanical mechanisms, such as, for example, dissolution, byproviding ultrasonic energy. In such configurations, sufficientultrasonic energy is provided to coupling member or members to disengagethem from the sleeve or sleeves.

In various embodiments, disengaging a single coupling member whichcloses a single sleeve from the sleeve allows the expandable device tobe expanded. For example, with reference to FIG. 2A, catheter assembly200 can be used to deliver an implant expandable implant 206 to atreatment area of a vasculature. Expandable implant 206 has a collapseddiameter for delivery, and sleeve 204 circumferentially surroundsexpandable implant 206 and is held closed by coupling member 224. Asdescribed in more detail below, bending of expandable implant 206 can becontrolled prior to full expansion (e.g., at an intermediate diameter)to help facilitate delivery to the desired position. Once expandableimplant 206 is in position relative to the treatment area, couplingmember 224 is disengaged from sleeve 204 and sleeve 204 is released,allowing expandable implant 206 to expand to a larger diameter.

As mentioned above, in various embodiments of the present disclosure, anexpandable implant can further comprise an intermediate configuration.In the intermediate configuration, the diameter of the expandableimplant is constrained in a diameter smaller than the expandedconfiguration and larger than the collapsed configuration. For example,the diameter of the expandable device in the intermediate configurationcan be about 50% of the diameter of the expandable device in theexpanded configuration. However, any diameter of the intermediateconfiguration which is less than the diameter of the expandedconfiguration and larger than the collapsed configuration is within thescope of the invention.

In such embodiments, the expandable implant can be expanded from thecollapsed configuration to the intermediate configuration once theimplant has been delivered near the treatment area of the vasculature ofa patient. The intermediate configuration can, among other things,assist in properly orienting and locating the expandable implant withinthe treatment area of the vasculature.

In various embodiments, an expandable implant can be concentricallysurrounded by two sleeves having different diameters. In suchconfigurations, a primary sleeve constrains the expandable implant inthe collapsed configuration. Once the collapsed configuration sleeve isopened, a secondary sleeve constrains the expandable implant in theintermediate configuration. As discussed above, the expandable implantcan be self-expanding, or the implant can be expanded by a device, suchas a balloon.

For example, with reference to FIG. 2A, a catheter assembly 200comprises an expandable implant 206 and sleeve 204. Secondary sleeve 204constrains expandable implant 206 to an intermediate configuration.Secondary sleeve 204 is held in position around expandable implant 206by secondary coupling member 224.

Catheter assembly 200 further comprises primary sleeve 208, whichconstrains expandable implant 206 in a collapsed configuration fordelivery to the vasculature of a patient. Primary sleeve 208 is held inposition around expandable implant 206 by primary coupling member 234.

Once expandable implant 206 is sufficiently close to the treatment areaof the vasculature, primary coupling member 234 is disengaged fromprimary sleeve 208, which releases primary sleeve 208 and allowsexpanded implant 206 to expand to a larger diameter.

With reference to FIG. 2B, after primary sleeve 208 has been expanded,secondary sleeve 204 constrains the expandable implant 206 in theintermediate configuration. In the intermediate configuration, asmentioned above and as described in more detail below, expandableimplant 206 can be oriented and adjusted (e.g., by bending and torsionalrotation) to a desired location within the treatment area of thevasculature.

In other embodiments of the present disclosure, a single sleeve can beused to constrain the expandable implant in both a collapsedconfiguration and an intermediate configuration. For example, withreference to FIGS. 3A-3D, catheter assembly 300 comprises an expandableimplant 306, a monosleeve 304, a primary coupling member 334, and asecondary coupling member 324.

Monosleeve 304 further comprises a plurality of secondary holes 332. Inthis configuration, secondary coupling member 324 is stitched or woventhrough secondary holes 332, constricting monosleeve 304 and expandableimplant 306 to the diameter of an intermediate configuration. In theintermediate configuration, the diameter of expandable implant 306 isless than the expanded diameter and larger than the diameter of thecollapsed configuration. In the intermediate configuration, as describedin more detail below, expandable implant 306 can be oriented andadjusted (e.g., by bending and torsional rotation) to a desired locationwithin the treatment area of the vasculature.

Monosleeve 304 further comprises a plurality of primary holes 330. Inthis configuration, primary coupling member 334 is stitched or woventhrough primary holes 330, constricting monosleeve 304 and expandableimplant 306 to the diameter of the collapsed configuration. The diameterof the collapsed configuration is selected to allow for delivery of theexpandable implant 306 to the treatment area of the vasculature of apatient.

Once expandable implant 306 has been delivered to a region near thetreatment area of the vasculature, primary coupling member 334 can bedisengaged from monosleeve 304, allowing expandable implant 306 to beexpanded to the intermediate configuration. Expandable implant 306 canbe oriented and adjusted (e.g., by bending and torsionally rotating) toa desired location within the treatment area of the vasculature. Afterfinal positioning, secondary coupling member 324 can be disengaged frommonosleeve 304, and expandable implant 306 can be expanded to theexpanded configuration.

Although a number of specific configurations of constraining members(for example, primary and secondary members) and sleeves (for example,primary and secondary sleeves) have been discussed, the use of anynumber and/or configuration of constraining members and any number ofsleeves is within the scope of the present disclosure.

In various embodiments, the catheter assembly further comprises asteering line. In such configurations, tension can be applied to thesteering line to displace the steering line and bend the expandableimplant. In various embodiments, the degree of bending of the expandabledevice relative to the catheter assembly is proportional to the amountof displacement of the steering line. Bending the expandable implantcan, among other things, allow the implant to conform to curvatures inthe vasculature of a patient. It can also assist in travelling throughcurved regions of vasculature.

For example, with reference to FIGS. 2A-2B, steering line 220 passesfrom the outside of the body of a patient, through catheter shaft 202,and is releasably coupled to expandable implant 206. In suchconfigurations, steering line 220 can be threaded through expandableimplant 206 such that tension applied to steering line 220 from outsideof the body of the patient causes expandable implant 206 to bend in adesired manner.

As a further example, with reference to FIG. 6, an expandable implant606 is illustrated. Steering line 620 is threaded along the surface ofexpandable implant 606.

In various embodiments, steering line 220 can comprise metallic,polymeric or natural materials and can comprise conventional medicalgrade materials such as nylon, polyacrylamide, polycarbonate,polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers; metals such asstainless steels, cobalt-chromium alloys and nitinol. Further, steeringline 220 can also be formed from high strength polymer fibers such asultra high molecular weight polyethylene fibers (e.g., Spectra®, DyneemaPurity®, etc.) or aramid fibers (e.g., Technora®, etc.). However, anymaterial that can be used to bend and/or steer an expandable implant iswithin the scope of the present disclosure.

With reference to FIGS. 7A-H, cross-sectional views of variousexpandable implant configurations are illustrated. In variousembodiments, an expandable implant can comprise a stent 705 and a graftmember 707, which are surrounded by sleeve 704. In such configurations,a steering line 720 can be threaded through stent 705, graft member 707,and/or sleeve 704 in a variety of different patterns. Such patterns can,among other benefits, facilitate the bending of the expandable implantby applying tension to (and corresponding displacement of) steering line720 from outside of the body. Further, such patterns can reduce orprevent steering line 720 from damaging tissue within the vasculature ofthe patient by limiting or preventing “bowstringing.” Bowstringingoccurs when a string or thread travels in a direct line between twopoints on the inside of a curve in an expandable graft. This can causethe string or thread to come into contact with and potentially damagetissue in the vasculature. Bowstringing and its effects on tissue canalso be reduced and/or minimized by sleeve 704 as sleeve 704 surroundssteering line 720 during bending and prior to full expansion of theexpandable implant.

As illustrated in FIGS. 7B-7H, steering line 720 can be woven throughany combination of stent 705, graft member 707, and sleeve 704. In eachfigure described below, a segment of a pattern is described. A steeringline can be woven between a stent, graft member, and sleeve in anycombination of these patterns. Alternatively, the steering line caninteract with an expandable implant and one or more sleeves in anymanner which allows steering line 720 to bend the expandable implant ina desired manner.

In FIG. 7B, steering line 720 is threaded between the inner wall ofsleeve 704 and stent 705. In FIG. 7C, steering line 720 passes between afirst apex 751 of stent 705 and the outer wall of graft member 707,passes between second apex 752 and the inner wall of sleeve 704, extendsinto and through the wall of graft member 707, reenters graft member707, passes between a third apex 753 of stent 705 and the inner wall ofsleeve 704, and passes between a fourth apex 754 and the inner wall ofsleeve 704. In FIG. 7D, steering line 720 passes between first apex 751and the outer wall of graft member 707, then between second apex 752 andthe inner wall of sleeve 704.

In FIG. 7E, steering line 720 passes between first apex 751 and theouter wall of graft member 707, extends through the outer wall of graftmember 707, reenters graft member 707, and passes between third apex 753and the outer wall of graft member 707. In FIG. 7F, steering line 720passes between the outside wall of graft member 707 and stent 705.

In FIG. 7G, steering line 720 passes from the inner wall of graft member707, through to the outer wall of graft member 707 between first apex751 and second apex 752, back through to the outer wall of graft member707, and back through to the inner wall of graft member 707 betweenthird apex 753 and fourth apex 754. In FIG. 7H, steering line 720 isdisposed against the inner wall of graft member 707. As discussedpreviously, FIGS. 7B-7G illustrate example patterns in which a steeringline can interact with an expandable implant. Any way in which asteering line interacts with an expandable implant to facilitate bendingof the implant is within the scope of the present disclosure.

In various embodiments, a catheter assembly can comprise more than onesteering line. For example, with reference to FIG. 9, catheter assembly900 comprises two steering lines 920. As described in relation to FIGS.7A-7G, steering lines 920 can be woven through the surface of expandableimplant 906. In various embodiments, steering lines 920 can exitcatheter shaft 902 and engage expandable implant 906 near the proximalend of expandable implant 906. In such configurations, steering lines920 can travel across and remain substantially in contact with thesurface of expandable implant 906 from the proximal end to the distalend. Steering lines 920 can then disengage the surface of expandableimplant 906 and become secured to catheter assembly 900. However,multiple steering lines 920 can interface with any portion of expandableimplant 906, including the proximal end, the distal end, and any portionbetween the two ends.

In various embodiments, steering lines 920 traverse and interact withthe surface of expandable implant 906 in a pattern which facilitatescontrollable bending of expandable implant 906. For example, asillustrated in FIG. 9, steering lines 920 can traverse the surface ofexpandable implant 906 such that, across a significant portion ofexpandable implant 906, both steering lines 920 are parallel to and inclose proximity with each other. Such a configuration allows the tensionapplied to steering lines 920 to work together to form a bend orcurvature in the same segment of expandable implant 906. Anyconfiguration of steering lines 920 and surface of expandable implant906 which allows for selective and controllable bending of expandableimplant 906 is within the scope of the present disclosure.

In various embodiments, steering lines can traverse a path across and/orthrough the surface of expandable implant that is at least partiallyparallel to and substantially covered by one or more sleeves.

In various embodiments, the catheter assembly can further comprise alock wire. In such embodiments, the lock wire can secure a steering lineor lines to the catheter assembly. For example, with reference to FIG.8, catheter assembly 800 comprises a catheter shaft 802, expandableimplant 806, two steering lines 820, and a lock wire 880. Lock wire 880passes from outside of the body of the patient, through catheter shaft802. Lock wire 880 exits a side port of the catheter shaft 802, engagessteering lines 820, then reenters catheter shaft 802 and continues tocatheter tip 818. In such a configuration, lock wire 880 releasablycouples steering lines 820 to catheter assembly 800. Any manner in whichlock wire 880 can interact with steering line or lines 820 to maintain areleasable coupling between steering line or lines 820 and catheterassembly 800 is within the scope of the present disclosure.

In various embodiments, each steering line can further comprise an endloop. For example, with reference to FIG. 9, each steering line 920comprises an end loop 922. Lock wire 980 can pass through each end loop922, securing each steering line 920 to catheter assembly 900. Anymethod of securing steering line or lines 920 to catheter assembly 900is within the scope of the invention.

In various embodiments, lock wire 980 can be formed from metallic,polymeric or natural materials and can comprise conventional medicalgrade materials such as nylon, polyacrylamide, polycarbonate,polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers; metals such asstainless steels, cobalt-chromium alloys and nitinol. Further, lock wire980 can also be formed from high strength polymer fibers such as ultrahigh molecular weight polyethylene fibers (e.g., Spectra®, DyneemaPurity®, etc.) or aramid fibers (e.g., Technora®, etc.). Any materialthat can provide sufficient engagement with and secure steering line 920to catheter assembly 900 is within the scope of the present disclosure.

In various embodiments, a catheter assembly used to deliver anexpandable implant comprises a catheter shaft, an expandable implant,one or more sleeves, one or more steering lines, and a lock wire. Insuch configurations, the expandable implant is capable of bending,through tension applied to the one or more steering lines andcorresponding displacement, to conform to curvature in the vasculatureof a patient.

For example, with reference to FIGS. 5A-D, a catheter assembly 500comprising an expandable implant 506 is illustrated. Catheter assembly500 further comprises two steering lines 520, a lock wire 580, a primarycoupling member 524, and a secondary coupling member 534. Primarycoupling member 524 is releasably coupled to primary sleeve 504.Secondary coupling member 534 is releasably coupled to secondary sleeve508.

Catheter assembly 500 is inserted into the vasculature of a patient, andexpandable implant 506 is advanced to a treatment area of thevasculature. Upon arriving at a location close to the treatment area,primary coupling member 524 can be disengaged from primary sleeve 504,allowing expandable implant 506 to be expanded to an intermediateconfiguration. In various embodiments, sleeve 504 can be removed fromthe vasculature once primary coupling member 524 has been disengaged.

With reference to FIG. 5B, upon expansion to an intermediateconfiguration, tension can be applied to steering lines 520, causingexpandable implant 506 to bend in a desired manner. For example,expandable implant 506 can bend in a direction aligned with the locationof steering lines 520. Once expandable implant 506 has been sufficientlybent, consistent tension is applied to steering lines 520 to maintainthe degree of bending.

In various embodiments, tension can be applied to steering lines 520 bypulling the lines from the outside of the body of the patient. In otherembodiments, steering lines 520 can be connected to a one more dials orother mechanisms for applying the tension at the trailing end ofcatheter shaft 502. In this configuration, the dial can be used to applya desired tension, as well as maintain the correct amount of tensiononce a desired angle of bending of expandable implant 506 has beenachieved. Various embodiments can also comprise an indicator, scale,gradient, or the like which demonstrates the amount of tension ordisplacement of the steering line, and/or the amount of bending inexpandable implant 506. In various embodiments, the catheter assemblycan comprise one more additional markings (e.g., on a handle) that allowa user to determine the orientation of the steering line with respect tothe vasculature.

After a sufficient degree of bending has been achieved in expandableimplant 506, the implant can be rotated for final positioning in thetreatment area of the vasculature. In various exemplary embodiments,lock wire 580 is engaged with steering lines 520 such that torsionalrotation of the catheter shaft causes expandable implant 506 to rotatewithin the vasculature. However, any configuration of catheter assembly500 which allows for rotation of expandable implant 506 is within thescope of the present disclosure.

In various embodiments, an expandable implant can further comprise oneor more radiopaque markers. In one embodiment, one or more radiopaquemarkers form a band around the distal end of the expandable implant. Inother embodiments, one or more radiopaque markers can be embedded in asleeve, such as a primary sleeve or a secondary sleeve. Further, one ormore radiopaque markers can be embedded in a catheter shaft. In theseconfigurations, the radiopaque markers can assist in deployment of anexpandable implant by providing increased visibility when observing theexpandable implant with a radiographic device, such as an x-ray machine.Any arrangement of radiopaque markers which assists in deployment of anexpandable implant is within the scope of the present disclosure.

In various embodiments, radiopaque markers can assist in orienting theexpandable implant by providing a profile view of the distal or proximalend of the expandable implant. For example, with reference to FIG. 4, anumber of potential profiles 491-495 of the distal and/or proximal endof an expandable implant 406 are illustrated. In such configurations,radiopaque markers located in the distal and/or proximal end ofexpandable implant 406 provide a profile view of the end of expandableimplant 406 when viewed by a radiographic device. Such profile views canbe used to properly orient expandable implant 406 by assisting a user indetermining the degree of rotation and/or orientation of a bend inexpandable implant 406.

For example, profile 491 represents a distal end of an expandableimplant 406 having an orientation substantially orthogonal to aradiographic image capture device, such as an x-ray camera. Profile 492represents a distal end of an expandable implant having an orientationless orthogonal than profile 491. Profile 493 represents a distal end ofan expandable implant 406 having an orientation less orthogonal thanprofile 492. Finally, profile 494 represents a distal end of anexpandable implant 406 having an orientation parallel to a radiographicimage capture device.

After expandable implant 506 has been properly oriented and locatedwithin the treatment area of the patient, secondary coupling member 534can be disengaged from secondary sleeve 508. Once secondary couplingmember 534 is disengaged from secondary sleeve 508, expandable implant506 can be expanded to a final position and diameter within thetreatment area. In various exemplary embodiments, secondary sleeve 508is removed from the vasculature. In other exemplary embodiments,secondary sleeve 508 remains in position circumferentially surrounding aportion of expandable implant 506.

With reference to FIG. 5C, after expandable implant 506 is in positionand expanded within the vasculature, lock wire 580 can be disengagedfrom catheter assembly 500. In various embodiments, lock wire 580 isdisengaged by applying sufficient tension from outside of the body ofthe patient. After lock wire is disengaged, steering lines 520 can bereleased from coupling with catheter shaft 502 and can be removed fromexpandable implant 506 and catheter assembly 500.

As illustrated in FIG. 5D, after primary and secondary coupling members524 and 534, steering lines 520, and lock wire 580 are removed fromcatheter assembly 500, catheter assembly 500 is fully disengaged fromexpandable implant 506, and can be removed from the vasculature of thepatient.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the spirit or scope of the disclosure. Thus, itis intended that the present disclosure cover the modifications andvariations of this disclosure provided they come within the scope of theappended claims and their equivalents.

Likewise, numerous characteristics and advantages have been set forth inthe preceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications can be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the disclosure, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. A catheter assembly comprising: a catheter; anexpandable device arranged near a distal end of the catheter; and two ormore steering lines releasably coupled to the expandable device, the twoor more steering lines each including circumferential portions, acircumferential portion of one of the two or more steering lines beingarranged on a circumferentially opposing side of a circumferentialportion of another of the two or more steering lines relative to aperimeter of the expandable device and each of the steering linesincluding at least one linear portion extending each of the steeringlines from about a proximal end to about a distal end of the expandabledevice to allow selective bending of the expandable device, the at leastone linear portion of each of the steering lines being positioned inclose proximity to each other along the expandable device, the at leastone linear portion of the two lines being essentially parallel with oneanother and essentially parallel with a longitudinal axis of theexpandable device.
 2. The catheter assembly of claim 1, wherein theportions of the steering lines extend circumferentially about theperimeter of the expandable device adjacent a proximal end.
 3. Thecatheter assembly of claim 2, wherein the portions of the steering linesthat extend circumferentially about the perimeter of the expandabledevice transition to extend toward a distal end of the expandablemedical device.
 4. The catheter assembly of claim 1, wherein the linearportions of the steering lines are parallel with one another.
 5. Thecatheter assembly of claim 1, wherein the steering lines are woventhrough the expandable device.
 6. The catheter assembly of claim 5,wherein the expandable device includes a stent coupled to a graft, andthe steering lines are woven through the stent and the graft.
 7. Thecatheter assembly of claim 1, wherein the steering lines extend betweena proximal end and a distal end of the expandable medical device, andthe steering lines remain substantially in contact with a surface of theexpandable device between the proximal end and the distal end of theexpandable medical device.
 8. The catheter assembly of claim 1, whereinthe steering lines exit the catheter and engage the expandable implantnear a proximal end of the expandable implant.
 9. The catheter assemblyof claim 1, wherein the steering lines are coupled to a mechanism forapplying tension at a trailing end of the catheter.
 10. A catheterassembly comprising: a catheter; an expandable device arranged near adistal end of the catheter; and two steering lines releasably coupled tothe expandable device, the steering lines each including circumferentialportions diametrically staggered at a proximal end and a distal end ofthe expandable medical device and at least one linear portion extendingfrom about the proximal end to about the distal end of the expandablemedical device, the at least one linear portion of the two lines beingessentially parallel with one another across a significant portion ofthe expandable device and essentially parallel with a longitudinal axisof the expandable device.
 11. The catheter assembly of claim 10, whereinthe steering lines are configured to bend the expandable device inresponse to tension applied to the steering lines.
 12. The catheterassembly of claim 11, further comprising a handle and mechanisms forapplying tension to the steering lines arranged at a trailing end of thecatheter.
 13. The catheter assembly of claim 10, wherein the expandabledevice includes a stent coupled to a graft, and the steering lines arewoven through the stent and the graft.
 14. The catheter assembly ofclaim 10, wherein the linear portions of the steering lines are parallelwith one another.
 15. A method of deploying an expandable device withinvasculature of a patient, the method comprising: arranging an expandabledevice arranged near a distal end of a catheter at a target locationwithin the vasculature; and applying tension to two steering linesreleasably coupled to the expandable device to bend the expandabledevice, the two or more steering lines each including circumferentialportions, a circumferential portion of one of the two or more steeringlines being arranged on a circumferentially opposing side of acircumferential portion of another of the two of the two or moresteering lines relative to a perimeter of the expandable device and eachof the steering lines including at least one linear portion extendingeach of the steering lines from about a proximal end to about a distalend of the expandable device to allow selective bending of theexpandable device, the at least one linear portion of each of thesteering lines being positioned in close proximity to each other alongthe expandable device, the at least one linear portion of the two linesbeing essentially parallel with one another and essentially parallelwith a longitudinal axis of the expandable device.
 16. The method ofclaim 15, wherein the steering lines extend between a proximal end and adistal end of the expandable medical device, and the steering linesremain substantially in contact with a surface of the expandable devicebetween the proximal end and the distal end of the expandable medicaldevice.
 17. The method of claim 15, wherein the steering lines arecoupled to a mechanism for applying tension at a trailing end of thecatheter.
 18. The method of claim 15, wherein the portions of thesteering lines extend circumferentially about the perimeter of theexpandable device adjacent a proximal end and the portions of thesteering lines that extend circumferentially about the perimeter of theexpandable device transition to extend toward a distal end of theexpandable medical device.
 19. The method of claim 18, wherein each ofthe steering lines include linear portions, and the linear portions ofthe steering lines are parallel with one another.